MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-10-10 for ENSOETM ECD02-A manufactured by Advanced Cooling Therapy Inc. D/b/a Attune Medical.
[123356191]
Notification: a company representative was informed about this incident during a routine in-service visit on (b)(6) 2018 from a nurse in the neurological icu. The nurse said the incident occurred "a few months ago". Device investigation: the device was returned for investigation on (b)(6) 2018 and was inspected by attune medical, senior director of operations, (b)(6). The device showed no signs of damage or deficiency and functioned correctly when connected to a blanketrol ii heat exchanger. The device did not contain any sharp edges, and the stiffness of both the main body of the device and the distal tip were similar to a typical production device. The investigation of the device did not reveal any device defects or non-conformances that may have contributed to the esophageal tear. Clinical investigation: attune medical clinical expert, dr. (b)(6), was consulted on the details of this incident. Because this incident involved a severely injured, intubated, poly-trauma patient with extensive cranio-facial injuries sustained from high-speed blunt trauma, it is difficult to determine both the timing and the etiology of the esophageal injury. The severity of the patient's injuries allow the distinct possibility that esophageal injury, along with other bone or organ injuries seen with severe blunt trauma, occurred as a result of the significant forces sustained during the patient's initial impact. Rapid deceleration is known to result in a variety of internal organ injuries, including solid organs (liver, spleen, kidney, etc. ) and hollow organs (intestine, esophagus, bladder, etc. ). As such, the patient's esophagus may have been damaged or torn prior to the patient's arrival to the neuro icu. Additionally, the esophageal injury may have been caused by placement of either the endotracheal or the orogastric tube, both of which were placed prior to the ensoetm. Finally, a small esophageal injury may have been exacerbated by placement of the ensoetm into an esophagus with an orogastric tube already in place. Labeling investigation: the dhr for lot #199100918a was reviewed to determine the version of the ifu that was used to manufacture this lot. (b)(4) instructions for use was used to manufacture this lot. (b)(4) contains the following warnings/precautions that may be relevant to this incident: (1) "the ensoetm may cause or exacerbate esophageal tissue damage in patients with known esophageal deformity or evidence of esophageal trauma. " and (2) "dual placement of other devices in the esophagus with the ensoetm is an unintended use and may result in patient harm. " insertion of the ensoetm into a patient with evidence of esophageal trauma is a known risk, and clinicians are appropriately warned that insertion of the ensoetm into these patients may cause additional harm. Furthermore, dual placement of devices in the esophagus (e. G. Attempting to place an ensoetm in patients with an orogastric tube already in place) is a known risk, and clinicians are warned that this action may cause patient harm. Conclusion the exact cause of, or the timing of, the esophageal injury is unable to be determined from the information available. The esophageal injury may have been present prior to the patient's arrival at the neuro icu, it may have been caused or exacerbated by insertion of the endotracheal tube or orogastric tube, and/or it may have been caused or exacerbated by dual placement of the ensoetm with an orogastric tube. If the ensoetm contributed to the esophageal tear, the cause was most probably user error due to both the insertion of the ensoetm into a patient with severe craniofacial trauma (and the consequent potential for esophageal injury) and the insertion of the ensoetm into a patient with an orogastric tube already in place.
Patient Sequence No: 1, Text Type: N, H10
[123356192]
The patient arrived at the neuro icu with severe craniofacial trauma described as occipital bone fracture, bilateral sphenoid fracture, first maxillary incisor fracture, temporal bone fracture extending into temporomandibular joint, and nasal bone fractures. These injuries were caused by jumping out of a car traveling approximately 50 mph. The patient was initially intubated with an endotracheal tube and a standard orogastric tube was placed. A nurse subsequently attempted to place the ensoetm without removing the orogastric tube. The nurse experienced some difficulty placing the ensoetm, but was able to successfully place the device. After several hours, the neuro icu staff noticed crepitus in the neck area. Upon inspection, they discovered an injury, described as a "tear" to the esophagus. Medical intervention was required to clip the tear. The patient survived the incident and was later discharged from the neuro icu.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010412492-2018-00001 |
| MDR Report Key | 7953505 |
| Report Source | USER FACILITY |
| Date Received | 2018-10-10 |
| Date of Report | 2018-10-10 |
| Date of Event | 2018-06-01 |
| Date Mfgr Received | 2018-09-11 |
| Device Manufacturer Date | 2018-01-09 |
| Date Added to Maude | 2018-10-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. ERIK KULSTAD |
| Manufacturer Street | 3440 S DEARBORN ST #215-SOUTH |
| Manufacturer City | CHICAGO IL 60616 |
| Manufacturer Country | US |
| Manufacturer Postal | 60616 |
| Manufacturer Phone | 8885344873 |
| Manufacturer G1 | ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL |
| Manufacturer Street | 3440 S DEARBORN ST #215-SOUTH |
| Manufacturer City | CHICAGO IL 60616 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60616 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENSOETM |
| Generic Name | ESOPHAGEAL THERMAL REGULATION DEVICE |
| Product Code | PLA |
| Date Received | 2018-10-10 |
| Returned To Mfg | 2018-10-05 |
| Model Number | ECD02-A |
| Lot Number | 199100918A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL |
| Manufacturer Address | 3440 S DEARBORN ST #215-SOUTH CHICAGO IL 60616 US 60616 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-10 |